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21 May 2012
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| [ Print-friendly version ] |
| A web-based coping and alcohol-Intervention program for children of parents with alcohol problems |
| ISRCTN | ISRCTN41545712 |
| ClinicalTrials.gov identifier | |
| Public title | A web-based coping and alcohol-Intervention program for children of parents with alcohol problems |
| Scientific title | Efficacy of a web-based Individual Coping and Alcohol-Intervention Program (web-ICAIP) for children of parents with alcohol problems: A randomized controlled trial |
| Acronym | Web-ICAIP |
| Serial number at source | N/A |
| Study hypothesis |
The intervention group, who have access to the web-ICAIP, in comparison to the control group, representing treatment as usual, will:
1. Improve their coping behavior 2. Improve their mental health 3. Postpone the onset of alcohol consumption or decrease their risky alcohol consumption |
| Lay summary | Lay summary under review |
| Ethics approval | Regional Ethical Review Board, Karolinska Institute, 1 December 2011, ref: 2011/1648-31/5) |
| Study design | Single centre parallel-group single-blinded randomised controlled intervention study |
| Countries of recruitment | Sweden |
| Disease/condition/study domain | Adolescents having at least one parent with alcohol problems |
| Participants - inclusion criteria |
1. Adolescents being 15-19 years old
2. Have at least one alcoholic parent 3. Approved of informed consent |
| Participants - exclusion criteria |
1. No easy access to computer and the Internet
2. Not sufficiently fluent in Swedish 3. Suicidal or self inflicted harm behavior |
| Anticipated start date | 02/01/2012 |
| Anticipated end date | 01/07/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 184 |
| Interventions |
The trial includes two arms. The first one is the waiting list control group, representing treatment as usual, which may include participating in a "face-to-face" support group or being active at self-help forums. The other group is the intervention group which has access to the web-ICAIP which is "locked" during the study period.
The web-ICAIP is derived from the manual-based "face-to-face" Individual Coping and Alcohol Intervention Program (ICAIP). Similar to the original ICAIP intervention, the web-ICAIP is divided into an alcohol and a coping theme, consisting of: 1. Three film-based lectures (each between 8-15 min) concerning alcohol problems within the family 2. One optional film-based lecture related to risky alcohol consumption 3. Four stories, so called readers' letters, which relates to coping and alcohol problems within the family 4. Various exercises related to alcohol and coping behavior 5. Automatic personalized feedback messages 6. Personalized feedback from experts 7. Participants formulate their own action plan for the future |
| Primary outcome measure(s) |
Study assessment take place at baseline and at 2 and 6 months following baseline.
1. Depressive symptoms will be measured using the Center for Epidemiological Studies Depression Scale (CES-DC) (four-point likert scales) where a higher total score indicate more depressive symptoms 2. Coping behavior will be measured using a Coping Behavior Scale for children of alcoholics (four-point likert scales) 3. Alcohol consumption will be measured using the short version of the Alcohol Use Disorders identification Test (AUDIT-C) 4. Questions will be asked related to whether or not the respondents have ever consumed alcohol to the point that he/she felt intoxicated, and respondents’ age of onset of drinking and intoxication |
| Secondary outcome measure(s) |
1. Program adherence will be measured in terms of completed film-based lectures and exercises
2. Overall life satisfaction will be measured by asking about the participants’ past, present, and future rating of his/her life on a ten-point “Ladder of life” representing life status from “worst” to “best” possible life imaginable |
| Sources of funding |
1. Swedish National Institute of Public Health (Sweden) ref: HFÅ 2009/133
2. Swedish Council for Working Life and Social Research (Sweden) ref: 2009-1705 |
| Trial website | |
| Publications | |
| Contact name | Dr Håkan Leifman |
| Address |
STAD
Stockholm Centre for Psychiatric Research and Education Stockholm County Council Health Care Provision and Karolinska Institutet Box 6031 |
| City/town | Stockholm |
| Zip/Postcode | 102 31 |
| Country | Sweden |
| hakan.leifman@sll.se | |
| Sponsor | Stockholm Prevents Alcohol and Drug Problems (STAD) (Sweden) |
| Address |
Stockholm Centre for Psychiatric Research and Education
Stockholm County Council Health Care Provision and Karolinska Insitutet |
| City/town | Stockholm |
| Zip/Postcode | 102 31 |
| Country | Sweden |
| stad.slso@sll.se | |
| Sponsor website: | http://www.stad.org/en/ |
| Date applied | 05/12/2011 |
| Last edited | 19/12/2011 |
| Date ISRCTN assigned | 19/12/2011 |
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